(77 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The device is described as a "Personal Medical Phone System" for transmitting vital signs, which does not inherently imply AI/ML use.
Yes
The device is intended to acquire, display, and transmit vital signs to a medical professional for analysis and response, which directly serves a medical purpose for patient care.
No
The device is described as a "Personal Medical Phone System" intended for acquiring, displaying, and transmitting vital signs for analysis and response, but it does not claim to perform diagnosis itself. The analysis and response are done by "medical professionals" and "Physicians."
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use mentions a "portable Personal Medical Phone System," which could imply hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description states the device is a "Personal Medical Phone System" intended for acquiring, displaying, and transmitting vital signs. Vital signs (like heart rate, blood pressure, temperature, etc.) are typically measured in vivo (on the living body), not in vitro (in a lab setting using samples).
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic tests performed on specimens.
Therefore, the CG-500 PMP4 appears to be a device for monitoring physiological parameters directly from the patient, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CG-500 PMP4 portable Personal Medical Phone System is intended for:
a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Web-based Call Center for analysis and obtain response
b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data
Product codes
DXH
Device Description
The provided text does not contain a detailed device description.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Patients, Medical professional via Web-based Call Center, Physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Card Guard Scientific Survival Ltd. c/o Mr. Alex Gonorovsky Regulatory Affairs, QA 2 Pekeris St., P.O. Box 527 Rehovot 76101 Israel
Re: K023689
Trade Name: CG-500 PMP4 Personal Medical Phone System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: September 15, 2002 Received: November 1, 2002
Dear Mr. Gonorovsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Alex Gonorovsky
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
V. Walter Tull
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Figure/0 description: The image shows the logo for Card Guard Scientific Survival LTD. The logo is in black and white and features the words "CARD GUARD" in bold letters above the words "Scientific Survival LTD." There is a line above the words "Scientific Survival LTD." To the right of the words is a line that resembles an EKG.
510(k) Number (if known):
The CG-500 PMP4 portable Personal Medical Phone System is intended for:
Patients wishing to acquire, display and transmit their vital signs to a medical a) professional via Web-based Call Center for analysis and obtain response
b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✔ OR (Per 21 CFR 801.109) (Optional Format 1-2-96)
Over-The-Counter Use
17
N. Dege Tu
510(k) Numbe